# FDA 483 - Genentech, Inc. - May 26, 2022

Source: https://www.keypedia.com/records/483/genentech-inc/3b630c1e-0dc5-44a8-a456-256f25c6a163

> FDA 483 for Genentech, Inc. on May 26, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Genentech, Inc.
- Inspection Date: 2022-05-26
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Genentech, Inc. in South San Francisco, CA, a drug substance and drug product manufacturer, identified two significant observations. The firm's laboratory controls were found to lack scientifically sound standards, specifically regarding unvalidated hold times for endotoxin samples and infrequent incubator cleaning. Additionally, the Quality Unit failed to adhere to written procedures for the qualification of critical reagents, leading to an improper cell bank potency comparison.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/genentech-inc/82cfc039-6c70-459b-ad38-2e0ed36626fa)
- [EIR - 2022-10-07](https://www.keypedia.com/records/eir/genentech-inc/c790563c-45ba-439c-8c24-6cd1f80fcf3f)
- [483 - 2011-09-27](https://www.keypedia.com/records/483/genentech-inc/18f90c1b-4f69-4c48-99f7-a22fc019324c)
- [483 - 2023-02-01](https://www.keypedia.com/records/483/genentech-inc/1cd09b7b-965e-44ed-b8cb-5c204ab45f19)
- [483 - 2024-03-12](https://www.keypedia.com/records/483/genentech-inc/7887b305-0de6-472c-b596-8cbd94e8d300)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [investigator](https://www.keypedia.com/people/riley-myers/22266738-1313-45db-902d-eaf4c63d4131)
- [Andrea George](https://www.keypedia.com/people/andrea-george/8e21cd66-64da-49f7-ba5e-4a9b9e103e96)
- [Janice Fringer](https://www.keypedia.com/people/janice-fringer/9f8cc92c-a3c7-4815-80d5-4d84300a8ce6)

Company: https://www.keypedia.com/companies/genentech-inc/709aa262-e8df-42fa-bec6-02673e7f52ec

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321